Friday’s biggest gaining and declining stocks

Atlanta, GA 6/22/12 (StreetBeat) -- Here are some of the most active stocks in U.S. trading Friday:

Gainers

Alexza Pharmaceuticals (Nasdaq:ALXA) rose 40% on Friday, rallying after the company said that it has resubmitted a new drug application for its Adasuve candidate with the Food and Drug Administration.

Harvest Natural Resources Inc. (NYSE:HNR) shares jumped 75%, Late Thursday, the energy company reached an agreement to sell some Venezuelan assets for about $725 million.

NPS Pharmaceuticals Inc. (Nasdaq:NPSP) shares added 11% after the company said it and partner Takeda Pharmaceutical have won support from a European regulatory committee recommending the companies’ treatment for short bowel syndrome.

U.S.-listed shares of Sony Corp. (NYSE:SNE) climbed 6%. The electronics and entertainment conglomerate reportedly is considering making an investment in fellow Japanese company Olympus.

Decliners

Protalix Biotherapeutics (AMEX:PLX) shares shed 7% after the company said that European medical authorities have ruled against recommending taliglucerase alfa, a treatment for Gaucher disease that Pfizer Inc. (NYSE:PFE) and Protalix have partnered on.

Repligen (Nasdaq:RGEN) shares fell 9% on Friday. Earlier, the company said that the FDA has requested more data on one of its drugs used for the treatment of pancreatitis.

Ryder System Inc. (NYSE:R) shares fell 11%. On Thursday the company issued a lowered outlook for its fiscal second quarter and full-year earnings.

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Wednesday’s biggest gaining and declining stocks

Shawshank, VA 5/2/12 (StreetBeat) – Shares of Charming Shoppes (Nasdaq: CHRS +23.39%) rose 24%. The company agreed to be bought by Ascena Retail Group Inc. (Nasdaq: ASNA +10.19%) for $7.93 a share, or about $890 million. Ascena’s shares also rose, up 13%.

Protalix BioTherapeutics (Nasdaq: PLX +15.19%) rallied 14%. The company said the Food and Drug Administration approved one of its treatments for adults with a confirmed diagnosis of type 1 Gaucher disease.

TripAdvisor Inc. (Nasdaq: TRIP +16.75%) jumped 16%. The company reported sharp growth in revenue for the first quarter, both on a year-over-year and a sequential basis.

Decliners

Chesapeake Energy Corp. (NYSE: CHK -12.99%) shares fell 13%. The company said in a regulatory filing that it had ended certain arrangements with CEO Aubrey McClendon. Also on Wednesday, analysts at Robert W. Baird cut their rating on Chesapeake to neutral from outperform.

American Depositary Shares of Banco Santander SA (NYSE: STD -6.50%) shed 6.4%, retreating with the broader Spanish market following recent data showing the country has dipped back into recession amid the European debt crisis.

Shares of OpenTable Inc. (Nasdaq: OPEN -15.98%) retreated 17%. Late Tuesday, the company reported first-quarter results and issued a financial outlook for the second quarter and the full year.

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FDA Extends Taliglucerase Alfa PDUFA Date to May 1, 2012

Palm Beach, FL 12/6/11 (StreetBeat) --Protalix BioTherapeutics, Inc. (AMEX: PLX), announced today that it received notification from the U.S. Food and Drug Administration (FDA) that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date of the New Drug Application (NDA) for taliglucerase alfa to May 1, 2012 , a three-month extension from the previous PDUFA date of February 1 , 2012. Taliglucerase alfa is the Company's proprietary plant cell expressed recombinant form of human Glucocerebrosidase (GCD), which is being developed for the treatment of Gaucher disease.

In November 2011 , the Company submitted certain clinical information regarding taliglucerase alfa in response to an FDA request. This request related mainly to the presentation of select data provided in the NDA. As this information was requested and provided within 90 days of the February 1, 2012 PDUFA goal date, the agency has the option to extend the PDUFA goal date to provide adequate time for the FDA to complete their review. A three month extension cycle is the standard period granted. No additional data were requested by the FDA in the notification, nor was the Company notified of any specific deficiency in the taliglucerase alfa NDA.

"We believe we have addressed the FDA's request," said Dr. David Aviezer, Protalix's President and Chief Executive Officer. "We look forward to working closely with the agency as it continues its review."

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